The explanted inlay was discarded by the facility and is not available for evaluation.The device history record review of the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Inlay shifts in position, corneal inflammation, and epithelial ingrowth are listed in the device labeling as known potential risks.Complaint reference number: (b)(4).
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The patient underwent implantation of the raindrop corneal inlay in the left eye on (b)(6) 2017.Within the first 2 postoperative weeks the patient presented with inferior inlay decentration and inlay repositioning was planned.During this procedure inflammation was observed in the interface in the area of the inlay, likely due to a corneal abrasion a few days prior.In addition, epithelial ingrowth was observed near the corneal flap hinge.On (b)(6) 2017, the inlay was explanted and a replacement inlay will be implanted once the inflammation resolves and the eye is stable.Additional information has been requested.
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